Using TriVerity™ to improve care for emergency patients with suspected infections

TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections

This study tests if using the TriVerity™ test can help doctors better treat emergency patients with suspected infections and symptoms like fever or fast heart rate.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Inflammatix (Industry-sponsored)
• Locations: 2 sites (Peoria, Illinois and 1 other locations)
• Trial ID: NCT06637904 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the TriVerity™ Acute Infection and Sepsis Test in managing emergency department patients who present with suspected infections and exhibit symptoms such as tachycardia or fever. Participants will be divided into two phases: a pre-phase where they receive standard care and a post-phase where their management is guided by the results of the TriVerity™ test. The study aims to compare various outcomes, including compliance with sepsis treatment protocols, appropriate use of antimicrobials, and overall patient disposition. The trial is conducted under an Investigational Device Exemption from the FDA.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who present to the emergency department with suspected acute infections and symptoms of tachycardia or fever.

Not a fit: Patients who have received systemic antibiotics, antivirals, or antifungals within the past week may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management of infections in emergency settings, potentially reducing complications and improving patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving infection management in emergency settings.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years
2. Participant presents to ED with ALL of the below:

   2.1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \& soft-tissue infection, meningitis/encephalitis, or any other infection), and 2.2. Either heart rate \>100 beats per minute or/and temperature \>38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and/or ED staging area/fast track area).
3. Able to provide informed consent, or consent by legally authorized representative.
4. Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).

Exclusion Criteria:

1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to presentation in the waiting room of the ED. Participants will not be excluded for use of:

   1. Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
   2. Topical antibiotics, topical antivirals or topical antifungal agents
   3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
   4. Single dose of one or combination of peri-operative (prophylactic) antibiotics
2. Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
3. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
4. Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
5. Participants previously enrolled in the present clinical trial.

Where this trial is running

Peoria, Illinois and 1 other locations

• OSF HealthCare Saint Francis Medical Center — Peoria, Illinois, United States (Recruiting)
• Johns Hopkins Department of Emergency Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Shailee Rasania

Conditions Sepsis; Infections; Tachycardia; Fever